that no contamination remains in the system before the blades are used for mixing new batches.

4. Accountability

The Production Manager is accountable for ensuring that inline cleaning of mixing blades is performed according to this SOP. The QC Manager is responsible for overseeing the verification process and ensuring that cleaning meets the required standards. The Laboratory Supervisor is accountable for reviewing cleaning results and ensuring that product quality is not compromised.

5. Procedure

5.1 Pre-Cleaning Setup

1. Ensure that all necessary cleaning agents, tools, and equipment are available and prepared for the cleaning process.
2. Check that all inline cleaning systems, such as spray nozzles, CIP (Clean-in-Place) systems, and water supply systems, are functioning properly and calibrated for optimal cleaning performance.
3. Verify that all personnel involved in the cleaning process are wearing the appropriate personal protective equipment (PPE), including gloves, goggles, and protective clothing.
4. Review the Batch Manufacturing Record (BMR) to determine the cleaning schedule and ensure that the required cleaning procedures are followed for the particular batch.

5.2 Inline Cleaning Process

1. Activate the inline cleaning system and initiate the cleaning cycle according to the manufacturer’s instructions for the cleaning agent and system type.
2. Ensure that the mixing blades are thoroughly cleaned by circulating the cleaning solution through the system to remove any residues or contaminants.
3. Monitor the cleaning process to verify that the required cleaning time and flow rates are achieved during the cycle. Adjust parameters if necessary to ensure complete cleaning of the mixing blades.
4. After the cleaning cycle is complete, flush the system with clean water to remove any residual cleaning agents. Ensure that no cleaning agent residue remains on the mixing blades.
5. Verify that the water used for rinsing meets acceptable quality standards and is free from contaminants. This may be done by performing a water quality test or by visual inspection.

5.3 Verification of Cleaning

1. After the cleaning cycle is complete, inspect the mixing blades for visible signs of cleanliness, such as the absence of product residue, discoloration, or any contamination.
2. Conduct microbiological or chemical testing (if necessary) to verify that the cleaning process has effectively removed any contaminants from the mixing blades. This may include swab tests or water rinse tests for microbial growth or chemical residue.
3. Document the results of the cleaning verification process in the Cleaning Verification Log (Annexure-1), including the date, time, results, and operator details.

5.4 Post-Cleaning Activities

1. Once the cleaning verification confirms that the blades are clean and free from contamination, the mixing blades can be used in the next production batch.
2. Ensure that all cleaning equipment, including hoses, nozzles, and pumps, are properly cleaned and sanitized after use to prevent cross-contamination during future cleaning cycles.
3. Document the cleaning procedure and ensure that the Cleaning Verification Log is completed and reviewed by the QC team for compliance.

5.5 Documentation and Record-Keeping

1. Document all cleaning activities in the Cleaning Verification Log (Annexure-1). Ensure that the log includes the batch number, date, time, operator, cleaning agent used, and any observations during the cleaning process.
2. Ensure that any deviations, corrective actions, or issues encountered during the cleaning process are documented in the Deviation Report (Annexure-2).
3. Review and approve the cleaning documentation, ensuring that all procedures were followed and that the mixing blades are verified as clean before use in subsequent batches.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• CIP: Clean-in-Place

7. Documents

1. Annexure-1: Cleaning Verification Log
2. Annexure-2: Deviation Report

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Cleaning Procedures in Pharmaceutical Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Verification Log

Batch Number	Cleaning Date	Cleaning Agent	Operator	Results	Remarks
12345	21/01/2026	Alkaline Detergent	John Doe	Pass	No residue detected

Annexure-2: Deviation Report

Batch Number	Deviation Description	Corrective Action	Resolved By
12345	Cleaning solution was not properly flushed	Re-flushed system with water	Jane Smith

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head